Ear Molding Device For Correcting Misshaped Ears

ABSTRACT

A system and method for correcting misshaped ears using a molding device having one or more braces supporting a scaphal mold. The one or more braces and the scaphal mold are adapted to retain the helix and the helical rim of a misshaped ear within a space defined between the one or more braces and the scaphal mold, and to maintain a substantially correct anatomical shape of the helix and the helical rim.

TECHNICAL FIELD

This invention relates to correcting misshaped ears., and moreparticularly to non-surgical correction of misshaped ears.

BACKGROUND

The ear consists of a complex arrangement of cartilage covered by skin,forming the characteristic shape of the ear (See FIG. 1). Some of themajor structures of the ear are the helix, which is the outer most partof the ear and is characterized by a roll or rim (helical rim). Thescapha (or scaphoid fossa) separates the helical rim from the antihelixwhich forms a defining curvature separating the scapha from the concha.The antihelix gives rise to a Y shaped structure having two crura. Thetwo crura form the fork of the Y and merge into the body of theantihelix. The area between the two crura is the triangular fossa. Thedeep recess leading to the auditory canal is the conchal bowl. It has anoblique and vertical component. The vertical component contributes toear projection and is continuous with the antihelix.

Depending on the survey, there may be an incidence of misshapen ordeformed ears in the newborn population of up to or greater than fortypercent. A few among the various types of congenital auriculardeformities are prominent ear, cup ear, lop ear, Stahl's ear, conchalcrus, misshapen ears, helical rim compression, and Tanzer I-IIconstricted ear.

Prominent ear is an ear in which the helical rim projects more than15-18 mm from the mastoid in an adult and more than 5 mm in an infant.Cup ear is characterized by incomplete curvature or formation of theantihelix and superior limb of the triangular fossa, and without thenormal curve of these structures, the ear “cups” forward. Lop ear ischaracterized by a “lidding” or folding over of the superior third ofthe ear. Stahl's ear, also called “Spock” ear, is characterized by a“transverse crus” extending off the Y of the antihelix, deforming thenatural curve of the helical rim and causing the ear to have a pointlike an elf's ear. Conchal crus is an abnormal crus or fold that extendsacross the oblique portion of the conchal floor to the vertical conchalwall, appearing to divide the ear in half at the level of the externalauditory canal.

Misshapen ears are variations of malformations of the auricularcartilage that do not fit into the above defined categories. These earsmay appear to be “crinkled”, folded, or collapsed in varying parts ofthe framework. Helical rim compression is characterized by an inwardbuckling of the rim disturbing its normal curvilinear contour. TanzerI-II constricted ears have increasingly severe grades of skin and/orcartilage absence or deficiency. In Tanzer I ears, the helical rim isrolled-in as there is a shortage or deficiency of skin along the innerrim that prevents the helical rim from being rolled out. With Tanzer II,the deficiency is greater and actually affects the scaphal cartilage aswell. Both surgical and non-surgical means have been used in an attemptto correct these and other deformities of the ear.

SUMMARY

Techniques are described for non-surgical correction of misshapen ears.Although various types of misshaped ears present at birth may involvedeformities of one or more anatomic structures of the ear, thetechniques presented below can be tailored to correct deformities of theone or more anatomic structures. Some of the anatomic structures of theear of interest are an antihelix, a superior limb of the triangularfossa, a helical rim, a concha, a base, and a scaphal area.

In one general aspect, a molding device for a human ear has one or morebraces, and a scaphal mold supported by the one or more braces. The oneor more braces and the scaphal mold are adapted to retain the helix andhelical rim within a space defined between the one or more braces andthe scaphal mold and to maintain a substantially correct anatomicalshape of the helix and the helical rim.

In another general aspect, a molding system for the human ear has acradle including a base section and a cover. The base section defines anopening dimensioned to accommodate the passage of the ear through theopening. The base section has a posterior surface and an anteriorsurface. The cover is releasably engageable with the base section. Whenengaged with the base section, the cover defines a compartment betweenan inner surface of the cover and an inner surface of the base section.The molding system for the ear also has an ear molding device, includingone or more braces and a scaphal mold supported by the one or morebraces. The one or more braces and the scaphal mold are adapted toretain the helix and the helical rim within a space defined between theone or more braces and the scaphal mold, and to maintain a substantiallycorrect anatomical shape of the helix and the helical rim.

In another general aspect, a method of correcting a misshaped earincludes placing a cradle base over the ear. The cradle base includes ananterior surface, a posterior surface, and an opening dimensioned toaccommodate passage of the ear. The cradle base is releasably engageablewith a cradle cover to define a compartment between an inner surface ofthe cover and the anterior surface of the base, such that the ear can bepositioned within the compartment. The method includes locating a splinton the anterior surface, such that the splint is arranged on theanterior surface in a position substantially corresponding to an area ofthe antihelix and the superior limb of the triangular fossa. The methodincludes placing a posterior surface of the ear between the base of theear and the helical rim over the splint, such that the splint maintainsa substantially correct anatomical configuration of the ear in the areaof the antihelix and the superior limb of the triangular fossa. Themethod includes retaining the helix in a space defined between a scaphalmold and one or more braces supporting the scaphal mold, such that thescaphal mold maintains a substantially correct anatomical configurationof the scaphal area of the ear.

Implementations may include one or more of the following features. Eachof the one or more braces can include a foot member positioned at an endof each brace distal to the scaphal mold. The foot member is adapted tofacilitate maintaining the substantially correct anatomical shape of thehelix. A surface of the one or more braces facing the scaphal mold candefine a substantially correct anatomic curvature for the helix. Thefoot can include a broad flat surface adapted for securing the earmolding device to a first surface. The one or more braces can include avertical support surface adapted to reversibly engage a second surface.The one or more braces can include a horizontal support surface adaptedto reversibly engage a third surface. The vertical and horizontalsupport surfaces when engaged to the second and third surfaces,respectively, can stabilize the ear molding device.

The one or more braces each can have an adjustable malleable supportadapted to retain an adjusted configuration of the brace. The scaphalmold can include a generally arc-shaped semi-cylindrical extension fromthe one or more braces having rounded edges. The extension can beadapted to maintain a substantially correct anatomical shape of thescaphal area of the ear. The scaphal mold can include an adjustablemalleable retainer located in an axis parallel to the arc of the scaphalmold. The retainer can be adapted to retain an adjusted configuration ofthe scaphal mold.

An adhesive backing can be dimensioned to fit the posterior surface ofthe base section and can define an opening corresponding to the openingin the base section. The adhesive backing can include an anterioradhesive surface adapted to adhere the posterior surface of the basesection, and a posterior adhesive surface adapted to adhere to aperiauricular skin surface. The base section can define a second openingposterior to the opening, such that a strip of the anterior surfaceseparates the opening from the second opening. A first stent can bearranged on the anterior surface and can be adapted to maintain asubstantially correct anatomical shape of the ear in an area of theantihelix and the superior limb of the triangular fossa. The strip ofthe anterior surface can be adapted to be broken when the cradle isseparated from the backing.

Each foot can include a broad flat surface adapted for securing the earmolding device to a portion of the anterior adhesive surface exposed bythe second opening. The base section and the cover can include avertical wall. A strip of double sided adhesive can be positioned on thevertical wall. The one or more braces have a vertical support surfaceadapted to reversibly engage the double sided adhesive positioned on thevertical wall. The one or more braces can have a horizontal supportsurface adapted to reversibly engage the cover when the cover is engagedwith the base section. The vertical and horizontal support surfaces whenengaged to the vertical wall and the cover, respectively, stabilize theear molding device. The one or more braces can be secured to theanterior surface. The cradle cover can be engaged with the cradle base.A kit can contain one or more cradles, one or more ear molding devices,and one or more adhesive backings.

DESCRIPTION OF DRAWINGS

FIG. 1 is an anatomical drawing of an ear showing the major structuresof the ear;

FIG. 2 is an exploded view of a system for correcting misshaped earsincluding a ear cradle with a base, a cover, an adhesive backing, and anear molding device configured to shape an ear in an area of the helix,helical rim, and scaphoid fossa;

FIG. 3 is a view of a cradle base with an adhesive backing applied to aposterior surface of the cradle base, and an ear molding device appliedto an anterior adhesive surface of the adhesive backing;

FIG. 4 is a posterior view of a cradle base;

FIG. 5 is a slightly inferior and lateral view of an ear molding device;

FIG. 6A is a lateral view of an ear molding device;

FIG. 6B is a top down view of an ear molding device;

FIG. 7 is a view of a cradle base and an ear molding device positionedaround an ear; and

FIG. 8 is a flow chart for treating deformities of an ear with a systemfor correcting misshaped ears.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

As shown in FIG. 1, an ear 1 has a complicated structure, composed ofcartilage covered by skin. Deformities involving various structures ofthe ear occur causing the ear to appear misshaped. The followingstructures are some of the structures of interest when discussingmisshaped ears. Progressing generally from peripheral to central regionsof the ear, the structures of interest are a helix 10, having a helicalrim 11. A scaphoid fossa (scapha) 12 is located between the helical rim11 and an antihelix 14. The antihelix 14 has a crura 15 forming asuperior limb (superior crus) 17 and an inferior limb (inferior crus) 19of a triangular fossa 16. A concha 13 is located in an area inferior tothe inferior limb of the triangular fossa. An ear lobe 9 hangs down fromthe ear, inferiorly. A retroauricular skin surface 18 can be seen from aposterior view as extending from the base of the ear. A posterior aspector skin surface 2 of the ear generally extending from the base of theear towards the helix is also depicted in the posterior view of the ear.

Abnormalities of one or more of these structures result in eardeformities, such as prominent ear, cup ear, lop ear, Stahl's ear,conchal crus, misshapen ears, helical rim compression, lidding, andTanzer I and II constricted ear. A non-surgical approach to thecorrection of these and other deformities of the ear can be accomplishedusing one or more of the components of a system for correcting misshapedears described in co-pending U.S. application Ser. No. 12/113,452, filedMay 1, 2008, the contents of which are incorporated by reference hereinin its entirety.

Referring to FIG. 2, an exploded view of system 100 for correcting amisshaped ear is illustrated. System 100 can be used to correctdeformities of one or more of above structures of the ear by molding orshaping the ear to create a substantially correct anatomicconfiguration. The system 100 has a cradle 20 in which the ear ispositioned to correct the deformities of the ear. Cradle 20 has a cradlebase 21 and a cradle cover 22. The cradle base 21 is releasablyengageable with the cradle cover 22 and, when engaged, defines acompartment between the cradle base 21 and the cradle cover 22. Thecradle base 21 and the cradle cover 22 are assembled and positionedaround the ear, such that the ear fits within the compartment, for thepurpose of correcting deformities that cause the ear to be misshaped.The cradle base and cradle cover can be made from biocompatiblematerials, such as thermoplastics, thermosets, and elastomers (includingPVC, polycarbonate, polyurethane, silicone, polypropylene andpolyethylene). The cradle base and cradle cover can be provided in arange of sizes designed to fit ears of differing proportions.

Referring to FIGS. 2 and 4, the cradle base 21 has a posterior surface26 that includes an opening 27 through which the ear can be positionedwithin the compartment defined by the base and cover, and a secondopening 28. Adhesive backing 23 has an anterior adhesive surface 24 anda posterior adhesive surface 25. Adhesive backing 23 is dimensioned suchthat the adhesive backing conforms to the shape of the posterior surfaceof the cradle base 21. The adhesive backing 23 has an openingdimensioned to correspond to the first opening 27 of the cradle base 21.The anterior adhesive surface 24 of adhesive backing 23 can be appliedto the posterior surface 26 of the cradle base 21. Once the adhesivebacking is applied to the posterior surface of the cradle base, an areaof the anterior adhesive surface 24 is exposed by the second opening 28in the cradle base 21. As seen in FIG. 4, adhesive backing can have afilm or protector 36 covering the posterior adhesive surface that can bepeeled off when the cradle base is to be secured to the retroauricularskin surface 18. In some implementations, a film or protective layer cancover the anterior adhesive surface exposed by the second opening 28.The adhesive backing can be any biocompatible adhesive backing, such as3M™ tape products 9917 or 1522.

Ear molding device 29 is configured to be positioned within thecompartment defined by the cradle base 21 and cover 22. In someimplementations, the ear molding device 29 is adjustably positionableupon an area of exposed anterior adhesive surface of adhesive backing 23made accessible by the second opening 28. In other implementations, apatch of double-sided adhesive material can be applied directly to theanterior surface 31 of the cradle base 21, such that the ear moldingdevice can be adjustably positioned and adhered directly to the patch ofdouble sided adhesive material. In other implementations, an adhesivecan be placed on the ear molding device 29 itself, allowing the earmolding device to be adhered to the anterior surface 31 of the cradlebase 21.

Although shown in FIG. 2 as two separate members, in otherimplementations, the cradle base 21 can be connected to the cradle cover22 through a flexible or hinged articulation allowing the cradle cover22 to move from an open position to closed position defining thecompartment with the cradle base 21. In some implementations, the cradlebase and cradle cover can include holes designed to allow for thepassage of air into the compartment and to the skin beneath the cradlebase.

The cover 22 can be attached to the base 21 by any reversible attachmentmechanism such as two or more snaps, or a hinge and one or more snaps,or hook and loop fasteners, or lug and notch, or a latch type mechanism,or any other type of fastening mechanism that securely and reversiblyattaches the cover to the base. The cover can be disengaged from thebase at any time by releasing the securing component, i.e., the snaps,the hook and loop fasteners, etc.

As shown in FIGS. 2 and 3, base 21 includes a rim (wall) 34 forming thewall of the compartment in which the ear is positioned to correctdeformities. Although as shown the majority of the rim or wall 34 of thecompartment is formed as part of the base 21, either or both the base 21and the cover 22 can be dimensioned to form all or part of the rim 34 orwall of the compartment, such that when the base and cover are engagedthe wall of the compartment is formed with dimensions configured toaccommodate an ear with the deformity to be corrected. The base 21 andcover 22 can be dimensioned to fit ears of different sizes depending onthe age and/or size of the patient being treated.

In some implementations, a detachment strip 32 separating the opening 27from the second opening 28 forms part of the cradle base. The cradlebase 21 has an anterior surface 31. A preformed stint (stent/splint) 33can be positioned on or formed integrally on the anterior surface 31 ofthe detachment strip 32 of the cradle base 21. The stint 33 can bepositioned in an area of the antihelix and the superior limb of thetriangular fossa to maintain a substantially correct anatomic shape ofthe antihelix and the superior limb of the triangular fossa in thatregion. In other implementations, the cradle base 21 includes opening27, but does not include opening 28, and the anterior surface extendsfrom opening 27 posterior to the posterior wall of the cradle base 21.The stint 33 can be positioned on a patch of double sided adhesiveplaced on the anterior surface of the cradle base 21 (or formed on theanterior surface 31), such that the stint 33 can be positioned in anarea of the antihelix and the superior limb of the triangular fossa tomaintain a substantially correct anatomic shape of the antihelix and thesuperior limb of the triangular fossa in that region.

In use, the cradle base 21 and the cradle cover 22 are assembled andpositioned around the ear 1, such that the base of the ear is positionedin the first opening 27, and the posterior adhesive surface 25 of theadhesive backing can be adhered to the retroauricular (or periauricular)skin surface 18 to maintain the cradle in position about the ear 1.

An area of anterior adhesive surface 24 is exposed by the second opening28. In some implementations, there is a cover over the anterior adhesivesurface that can be removed to expose the anterior adhesive surface. Theexposed anterior adhesive surface 24 can be used to tack the skin on theposterior aspect 2 of the ear 1 down after the ear is rolled out overthe stint 33, which is positioned in the area where the antihelix andthe superior limb of the triangular fossa are to be molded. An earmolding device 29 is positioned over the helical rim in a position tomold the helix, helical rim, and/or the scaphoid fossa, and adhered tothe exposed anterior adhesive surface 24. In some implementations, adouble adhesive strip 35 (other implementations can use hook and loopfasteners), having adhesive on both sides can be positioned on theinside surface of the wall 34 of the cradle proximate to the position ofthe ear molding device 29, such that the ear molding device 29 can alsobe adhered to the inner adhesive surface of adhesive strip 35. Ininstances where the ear is too small for the ear molding device to bepositioned in contact with adhesive strip 35 a shim having adhesive onboth sides can be inserted in order to secure the ear molding device 29to the wall 34, if desired.

As shown in FIGS. 5, 6A and 6B, ear molding device 29 is configured tomold the scaphoid fossa, helix, and the helical rim. In someimplementations, the ear molding device 29 can be used expand the skinand cartilage in the area of the helical rim and the scaphoid fossa inaddition to molding the shape of the scaphoid fossa, helix, and thehelical rim. The ear molding device 29 has a scaphal mold 55 configuredto mold the scaphoid fossa into a substantially correct anatomic shape.The exterior surface of the scaphal mold 55 is made from a biocompatiblematerial, such as urethane. Typically, it is desirable to ensure thatthe scaphal mold 55 is free from sharp or hard edges, preventing thescaphal mold 55 from exerting undue pressure on the skin so as to avoidpressure necrosis of areas of skin in contact with the scaphal mold. Thescaphal mold is generally a semi-cylindrical extension from legs (orbraces) 51 and 52 having rounded edges and shaped to maintain thesubstantially correct anatomical shape of the scaphal area 12 of the ear1. As will be discussed below, the inner curvature of the scaphal mold55 facing the legs 51 and 52 cooperates with inner surface of legs 51and 52 to form a space therewith configured to mold the helix andhelical rim during their growth while in the ear molding device, suchthat the growth of the helix and helical rim conforms to a curvaturedefined by the space between the scaphal mold and the legs.

Leg 51 and leg 52 each have a generally vertical support 65 and 66 and agenerally horizontal support 63 and 64, respectively when viewedrelative to being positioned on the cradle base. As illustrated, thescaphal mold 55 extends downward from the right and left legs 51 and 52generally in a direction parallel to the vertical supports 65 and 66.The scaphal mold 55 generally has a rounded edge for contacting the skinin the scaphoid fossa 12 and is generally formed in an arc matching asubstantially correct anatomic curvature of the ear in an area of thehelical rim where correction of the shape of the helix, helical rimand/or scaphoid fossa is desired. Instead of an arc, other dimensionallysimilar shapes can be used. Preferably, edges contacting a skin surfacethat might cause pressure necrosis of the skin should be avoided. Asshown in FIG. 6A, the inner curve of the scaphal mold is dimensioned toaccommodate the helical rim, while at the same time allowing the scaphalmold to engage an inner surface of the helix, allowing traction to beplace on the skin and cartilage of the ear in the area of the scaphoidfossa and the inner surface of the helix, if desired.

Positioned within the scaphal mold 55 is a malleable retainer 60 thatcan be used to adjust the curvature of the scaphal mold 55 to thesubstantially correct anatomic shape for the scaphal area 12 of the ear.The scaphal mold 55 is positioned in the scaphoid fossa when correctinga deformity of the scaphoid fossa, helix, and/or the helical rim. Priorto positioning the scaphal mold 55 in the scaphal area 12 of the ear,the curvature of the scaphal mold can be adjusted by bending themalleable retainer 60 to a desired (e.g., substantially correct)anatomic shape. The malleable retainer 60, having an initial shape of anarc, can be constructed to retain a desired curvature as adjusted, thus,maintaining the scaphal mold in a configuration to mold the scaphal area12 of the ear into a substantially correct anatomic shape.

The ear molding device 29 has a right leg 51 and a left leg 52, having aright foot 53 and left foot 54, respectively. In some implementations,the right leg 51 and left leg 52 are separated by a variable space. Inother implementations instead of two legs, the ear molding device can bea single unitary piece having one leg, which can have a second malleableretainer in the foot section to help maintain a desired shape. In otherimplementations, there may be more than two legs. Legs 51 and 52 can beformed from a biocompatible material such as thermoplastics, thermosetsand elastomers (including PVC, silicone, and propylene).

Feet 53 and 54 have a flat surface configured to be positioned on theanterior adhesive surface 24 exposed by the second opening 28, or ifthere is not second opening 28, then feet 53 and 54 can be positionedeither directly onto the anterior surface 31 (by adhesive on each foot),or onto a biocompatible double sided adhesive patch positioned on theanterior surface 31. Feet 53 and 54 are fixedly secured by the adhesivein a position to correct the anatomical deformities of the helix 10,helical rim 11, and scaphal area 12. The feet can be placed in anylocation on the exposed adhesive surface 24, such that the scaphal mold55 of the ear molding device 29 is placed in an area of the scaphoidfossa to maintain and mold the scaphoid fossa, helical rim, and helix ina substantially correct anatomic shape.

Legs 51 and 52 along with feet 53 and 54 form a curvature on their innersurface (facing the scaphal mold) configured to mold the helix to asubstantially correct anatomic shape, and allow the helix and helicalrim to grow along the curvature conforming to a substantially correctanatomic shape. Malleable supports 61 and 62 provide a further supportstructure to ear molding device 29, allowing the curvature of the legsto be adjusted to maintain the scaphal mold and/or the inside curvatureof the legs in a desired position to correct deformities of the helix,helical rim, and scaphal area. In some implementations, the outersurface of legs 51 and 52 are attached to malleable supports 61 and 62,respectively. In other implementations, the malleable supports can be inother positions with respect to the legs, such as inside of the legsrather than on the outside of the legs. Malleable supports 61 and 62 canbe connected to malleable retainer 60, allowing for adjustment of theear molding device in all three dimensions.

Horizontal support 63 and 64 have an outer surface that is configured tobe contacted by the cradle cover 22 when the cover is engaged with thecradle base 21. The horizontal supports 63 and 64 can reversibly engageor contact the cover when the cover is engaged with the cradle base, andwhen the cover is removed from the cradle base the horizontal supportstructures disengage from the cover. The contact between the surfaces ofhorizontal supports 63 and 64 and the cradle cover 22 provides anadditional stability to the ear molding device resisting the tractionexerted by the ear on the ear molding device and deformation of theshape of the ear molding device. If the malleable supports 61 and 62 arepositioned on the outside surface of the legs 51 and 52, then themalleable support have a surface that contacts the cradle cover 22. Insome implementations, the horizontal supports 63 and 64 do not contactcradle cover 22.

As discussed above, ear molding device 29 can also contact the cradlewall 34, if desired. Vertical supports 65 and 66 have an outer surfacethat is configured to be contacted by the cradle wall 34. When the outersurfaces of vertical supports 65 and 66 are placed in contact with thecradle wall 34, adhesive strip 35 can be used to adhere the surfaces 65and 66 to the cradle wall 34, with or without the use of shims dependingon the size of the ear being corrected. In some implementations, the earmolding device can provide tension or traction on the skin and cartilageof the area of the helix and scaphoid fossa, promoting the growth of theskin and cartilage in this area.

In some implementations, the ear molding device 29 is positioned andmaintained in position by the securement provided by the feet. In otherimplementations, contact with one or both of the cradle cover 22 andcradle wall 34 provide support to the ear molding device 29 when in use.In some implementations, the contact with the anterior surface 31, thecradle wall 34 and the cradle cover 32 combine to maintain the shape andposition of the ear molding device with respect to the forces exerted bythe ear during the molding process.

The malleable retainer 60, right malleable support 61, and leftmalleable support 62 can be made from any malleable material, such asaluminum, copper, or silver. In other implementation, the ear moldingdevice 29 can be dimensioned in different configurations of sizes andshapes without the malleable materials, such that a size and shape isselected that will provide the desired (substantially anatomicallycorrect) molding characteristics for any deformities of the helix,helical rim, and the scaphoid fossa without having to shape the earmolding device to the desired configuration using the malleable retainer60, the right malleable support 61, and the left malleable support 62.

System 100 is used to correct deformities of the ear involving thehelix, antihelix, helical rim, and/or scaphoid fossa, such as cup ear,lop ear, Stahl's ear, helical rim compression/irregularities, anddeformities in which there is a deficiency of skin and/or cartilage,such as Tanzer I and Tanzer II. As shown in FIG. 8, a system forcorrecting deformities of the ear includes assessing 802 the ear todetermine if there are any deformities of the antihelix, superior crus,scaphoid fossa, helix, and/or helical rim. After determining 803 whichdeformities of the ear are present, selection 804 of an appropriatelysized cradle and ear molding device can be made. If present, theadhesive cover 36 can be removed from the posterior adhesive surface 25of the adhesive backing 23 positioned on the posterior surface of thecradle base 21 prior to positioning the cradle about the ear. The cradlebase 21 is placed 805 around the ear 1 by passing the ear through thefirst opening 27 of cradle base 21. The cradle base 21 is positioned 806such that the stint 33, if necessary, is located in an area of theposterior aspect of the ear to correct a deformed or missing (ormisshaped) antihelix 14/superior crus 17. Using the stint 33, theantihelix/superior crus can be molded to the substantially correctanatomic shape. When the cradle is in the correct position, the cradlebase 21 is secured 807 in position by adhering the posterior adhesivesurface to the skin surrounding the base 3 of the ear, including theretroauricular skin surface 18.

The molding device 29 is shaped 808 for positioning over the helical rim11 in the area of the scaphoid fossa. A determination 809 is made as towhether the skin and/or cartilage needs to be expanded (discussedbelow). If the skin and/or cartilage need to be expanded, glue isapplied 810 to selected areas of the ear to be placed in contact withthe ear molding device 29. Then after the glue has been applied, or ifno glue is necessary, the ear molding device 29 is placed 811 over thehelical rim, such that the scaphal mold 55 of the ear molding device 29is positioned in an area of the scaphoid fossa identified to correctdeformities of the helix, helical rim, and scaphoid fossa, and such thatthe helix and the helical rim are positioned in the space definedbetween the scaphal mold 55 and the legs 51 and 52. A cover over theanterior adhesive surface, if present, can be removed. The ear can beadvanced 812 over the stint 33, and the right foot 53 and left foot 54can be adhered or secured to the exposed anterior adhesive surface 24,along with an area of skin on the posterior aspect 2 of the ear beingrolled out over the anterior adhesive surface, as the ear molding deviceis fixed in place. In some implementations, a patch of double adhesivecan be used, if there is not a second opening that exposes an anterioradhesive surface. As positioned, the helix rest along the curve createdby the feet 53 and 54 and the inner surface of the legs 51 and 52,defining a substantially correct anatomic curvature for the developmentof the helix and helical rim as the ear grows. The cradle cover 22 canthen be applied 813 to the cradle base.

For ears having a deficiency of skin and/or cartilage, the ear moldingdevice 29 can be used to grip the helical rim and expand the dimensionsof the ear in the area of the inner surface of the helical rim and thescaphoid fossa by putting a lateral force on the ear pulling the ear outto expand the cartilage and skin. Expansion of the skin and cartilagecan be used to correct deformities such as Tanzer I and II, which appearlike lop ear, but there have a deficiency of skin (Tanzer I and II) andcartilage (Tanzer II) on the inner surface of the helix and the helicalrim that prohibits rolling the rim out.

To grip the helical rim and apply tension to the ear, a bonding agentcan be used, such as medically approved glue, for examplecyanomethacrylate or cyanoacrylate. The bonding agent can be appliedselectively to portions of the ear which are placed in contact with theear molding device 29 to maintain tension and prevent the ear fromslipping out of the ear molding device. The ear molding device 29 can beadhered to anterior adhesive surface and to the inner wall 34 of thecradle base 21 proximate to the ear molding device in order to morefirmly fix the ear molding device in place to resist any opposingtension generated by the ear.

After positioning the cradle base 21 around the ear, and positioning thescaphal mold 55 of the ear molding device 29 in the scaphoid fossa, andfixedly securing the feet to the anterior adhesive surface, the cradlecover 22 is engaged with the cradle base 21. As discussed above, thecradle cover 22 can be positioned in contact with the horizontal supportsurfaces of the legs, providing additional support to maintain both theshape and the fixed position of the ear molding device. This additionalsupport provided by the cradle cover 22 helps to prevent deformation ofthe ear molding device and possible movement caused by the tensionexerted by the ear. Thus, the design of the cradle and the ear moldingdevice complement each other to create a additive reinforcement of boththe shape of the ear molding device, and the fixed positioning of theear molding device after placement. Additionally, this helps maintaintension provided by the ear molding device on the ear in the area of thehelix, helical rim and scaphoid fossa.

When correcting the shape of the misshaped ear, the duration oftreatment with the above described system depends on the age of theinfant or neonate at the time of diagnosis. An earlier diagnosis canshorten the duration of treatment. For example, when treatment begins atabout 1 week of age, the duration of the treatment may be in the rangeof 6 to 8 weeks. However, if the diagnosis is not made until 3 weeks ofage, then the duration of treatment may be in the range of 4 to 6months. It may be necessary in cases where the cartilage and skin needto be expanded to repeat the process two or three times in order toachieve the necessary growth of the skin and cartilage and mold the earto a substantially correct anatomic shape.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made. For example, thesize and shape of various components may be altered and differentmaterial may be used to make the various components. Different ways tosecure the components in their desired positions can be used.Accordingly, other implementations are within the scope of the followingclaims.

1. A molding device for a human ear, wherein the ear includes anantihelix, a superior limb of the triangular fossa, a helix, a helicalrim, a base, a concha, and a scaphal area, the molding devicecomprising: one or more braces; and a scaphal mold supported by the oneor more braces, wherein the one or more braces and the scaphal mold areadapted to retain the helix and helical rim within a space definedbetween the one or more braces and the scaphal mold, and to maintain asubstantially correct anatomical shape of the helix and the helical rim.2. The ear molding device of claim 1, wherein each of the one or morebraces includes a foot member positioned at an end of the brace distalto the scaphal mold, the foot member adapted to facilitate maintainingthe substantially correct anatomical shape of the helix.
 3. The earmolding device of claim 2, wherein a surface of the one or more bracesfacing the scaphal mold defines a substantially correct anatomiccurvature for the helix.
 4. The ear molding device of claim 2, whereinthe foot includes a broad flat surface adapted for securing the earmolding device to a first surface.
 5. The ear molding device of claim 1,wherein the one or more braces includes a vertical support surfaceadapted to reversibly engage a second surface.
 6. The ear molding deviceof claim 5, wherein the one or more braces include a horizontal supportsurface adapted to reversibly engage a third surface.
 7. The ear moldingdevice of claim 6, wherein the vertical and horizontal support surfaceswhen engaged to the second and third surfaces, respectively, stabilizethe ear molding device.
 8. The ear molding device of claim 1, whereinthe one or more braces each comprise an adjustable malleable supportadapted to retain an adjusted configuration of the brace.
 9. The earmolding device of claim 1, wherein the scaphal mold includes a generallyarc-shaped semi-cylindrical extension from the one or more braces havingrounded edges, and the extension is adapted to maintain a substantiallycorrect anatomical shape of the scaphal area of the ear.
 10. The earmolding device of claim 9, wherein the scaphal mold includes anadjustable malleable retainer located in an axis parallel to the arc ofthe scaphal mold, and the retainer is adapted to retain an adjustedconfiguration of the scaphal mold.
 11. A molding system for a human ear,wherein the ear includes an antihelix, a superior limb of the triangularfossa, a helix, a helical rim, a base, a concha, and a scaphal area, themolding system comprising: a cradle comprising: a base section definingan opening dimensioned to accommodate the passage of the ear through theopening, the base section including a posterior surface and an anteriorsurface; a cover releasably engageable with the base section, whereinthe cover, when engaged with the base section, defines a compartmentbetween an inner surface of the cover and an inner surface of the basesection; and an ear molding device comprising: one or more braces; and ascaphal mold supported by the one or more braces, wherein the one ormore braces and the scaphal mold are adapted to retain the helix andhelical rim within a space defined between the one or more braces andthe scaphal mold, and to maintain a substantially correct anatomicalshape of the helix and the helical rim.
 12. The molding system of claim11 comprising an adhesive backing dimensioned to fit the posteriorsurface of the base section and defining an opening corresponding to theopening in the base section, wherein the adhesive backing includes ananterior adhesive surface adapted to adhere to the posterior surface ofthe base section, and a posterior adhesive surface adapted to adhere toa periauricular skin surface.
 13. The molding system of claim 12,wherein the base section defines a second opening posterior to theopening, such that a strip of the anterior surface separates the openingfrom the second opening.
 14. The molding system of claim 13 furthercomprising a first stent arranged on the anterior surface adapted tomaintain a substantially correct anatomical shape of the ear in an areaof the antihelix and the superior limb of the triangular fossa.
 15. Themolding system of claim 13, wherein the strip of anterior surface isadapted to be broken when the cradle is separated from the backing. 16.The molding system of claim 13, wherein each of the one or more bracesincludes a foot member positioned at an end of each brace distal to thescaphal mold, the foot member adapted to facilitate maintaining thesubstantially correct anatomical shape of the helix.
 17. The moldingsystem of claim 16, wherein a surface of the one or more braces facingthe scaphal mold, including a surface of each foot of each brace,defines a substantially correct anatomic curvature of the helix.
 18. Themolding system of claim 16, wherein each foot includes a broad hatsurface adapted for securing the ear molding device to a portion of theanterior adhesive surface exposed by the second opening.
 19. The moldingsystem of claim 11, wherein the base section and the cover include avertical wall.
 20. The molding system of claim 19 comprising a strip ofdouble sided adhesive positioned on the vertical wall.
 21. The moldingsystem of claim 20, wherein the one or more braces have a verticalsupport surface adapted to reversibly engage the double sided adhesivepositioned on the vertical wall.
 22. The molding system of claim 21,wherein the one or more braces have a horizontal support surface adaptedto reversibly engage the cover when the cover is engaged with the basesection.
 23. The molding system of claim 22, wherein the vertical andhorizontal support surfaces when engaged with the vertical wall and thecover, respectively, can stabilize the ear molding device.
 24. Themolding system of claim 11, wherein the one or more of the bracescomprise an adjustable malleable support adapted to retain an adjustedconfiguration of the brace.
 25. The molding system of claim 11, whereinthe scaphal mold includes a generally arc-shaped semi-cylindricalextension from the one or more braces having rounded edges, and theextension is adapted to maintain a substantially correct anatomicalshape of the scaphal area of the ear.
 26. The molding system of claim25, wherein the scaphal mold comprises an adjustable malleable retainerlocated in an axis parallel to the arc of the scaphal mold, and theretainer is adapted to retain an adjusted configuration of the scaphalmold.
 27. The molding system of claim 12 comprising a kit containing oneor more cradles, one or more ear molding devices, and one or moreadhesive backings.
 28. A method of correcting a misshaped ear, whereinthe ear includes an antihelix, a superior limb of the triangular fossa,a helix, a helical rim, a base, a concha, and a scaphal area, the methodcomprising: placing a cradle base over the ear, wherein the cradle baseincludes an anterior surface, a posterior surface, and an openingdimensioned to accommodate passage of the ear, and wherein the cradlebase is releasably engageable with a cradle cover to define acompartment between an inner surface of the cover and the anteriorsurface of the base, such that the ear is positioned within thecompartment; locating a splint on the anterior surface, such that thesplint is arranged on the anterior surface in a position substantiallycorresponding to an area of the antihelix and the superior limb of thetriangular fossa; placing a posterior surface of the ear between thebase of the ear and the helical rim over the splint, such that thesplint maintains a substantially correct anatomical configuration of theear in the area of the antihelix and the superior limb of the triangularfossa; and retaining the helix in a space defined between a scaphal moldand one or more braces supporting the scaphal mold, such that thescaphal mold maintains a substantially correct anatomical configurationof the scaphal area of the ear.
 29. The method of claim 28 comprisingsecuring the one or more braces to the anterior surface.
 30. The methodof claim 29 comprising engaging the cradle cover with the cradle base.